New Clinical Trial Regulation: new transition phase, possible delays in the processing of substantial modifications, and information sessions for sponsors

date: 09/01/2023

The new Clinical Trial Regulation 536/2014 (CTR) entered into force on 31 January 2022. This new regulation on clinical trials applications of medicines for human use aims to simplify administration and harmonise legislation within the European Union. On 31 January 2023, a new transition phase will start and from then on all initial clinical trial applications have to be submitted via CTIS. The FAMHP is organising two information sessions on the clinical trials regulation.

Mandatory submission of initial clinical trials through CTIS from 31 January 2023
On 31 January 2022, Regulation 536/2014 or Clinical Trials Regulation (CTR) came into application with the Clinical Trials Information System (CTIS) as single entry point for sponsors and regulatory authorities of clinical trials submitted according to Regulation 536/2014. Until 30 January 2023, clinical trial sponsors could choose whether to submit an initial clinical trial application in line with the Clinical Trials Directive (Directive 2001/20/EC) or via CTIS. From 31 January 2023, submission of initial clinical trial applications via CTIS becomes mandatory.

By 31 January 2025, all trials will be governed by the new Regulation. Therefore, ongoing clinical trials approved under the current Clinical Trials Directive have to be fully transitioned to CTIS before 31 January 2025.
Possible delays in the processing of substantial modifications
Clinical trial submissions in line with CTR are our main priority. Implementation of this new regulation also means that we have to master new skills and competences.

  • We recommend to submit all initial submissions in line with CTR, as the mandatory submission will enter into force very soon.
  • This will impact the timing of all other submissions. We foresee significant delays in the treatment of substantial amendments and substantial modifications in dossiers submitted in accordance with the Directive or the pilot project. We apologise for this inconvenience and do our best to minimise these delays as much as possible.

Save the date: information sessions on the Clinical Trials Regulation 
A general session on the Clinical Trials Regulation will be organised for all sponsors on 10 March 2023 in the FAMHP building (Avenue Galilée 5/03, 1210 Brussels). The program of this session is still in draft, but the session is intended to exchange experiences of national competent authorities (NCAs), ethics committees and sponsors in the first year of CTR implementation, to provide sponsors with regulatory clarifications, share information on European initiatives and working groups and zoom in on the collaboration with the College. We will make the time to answer some of your questions. 

A second session will be held on 13 March 2023 (in the morning). This half day will focus on early phase clinical trials in CTR, discussing main points of attention and best practices in order to increase predictability of applications and reducing the number of evaluation questions. 

To register for the information session(s), please send an e-mail to before 15 February 2023 with the following subject: “registration CTR info session 2023”. Please clearly state which day you want to register for: 10 March, 13 March or both. 

Because of the limited capacity of the auditorium, we ask you to limit registration to two persons per organisation. There will be no possibility to connect virtually, but a pdf version of the presentations can be shared afterwards.

Questions from sponsors on the topics mentioned above are welcome. The questions and answers that match the foreseen topics (and can be treated in the foreseen time slots) will be answered during the sessions. Please send your questions to before 31 January 2023 with the following subject: “Q&A CTR info session 2023”.

Last updated on 09/01/2023